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TPLC
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show TPLC since
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2019
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2024
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Device
light, surgical, ceiling mounted
Product Code
FSY
Regulation Number
878.4580
Device Class
2
MDR Year
MDR Reports
MDR Events
2019
444
444
2020
439
439
2021
380
380
2022
430
430
2023
661
661
2024
155
155
Device Problems
MDRs with this Device Problem
Events in those MDRs
Detachment of Device or Device Component
1148
1148
Peeled/Delaminated
737
737
Corroded
277
277
Crack
190
190
Degraded
113
113
Flaked
108
108
Break
95
95
Material Integrity Problem
85
85
Mechanical Problem
82
82
Device Fell
51
51
Fluid/Blood Leak
43
43
Material Erosion
42
42
Leak/Splash
40
40
Material Fragmentation
40
40
Fracture
27
27
No Apparent Adverse Event
27
27
Use of Device Problem
18
18
Material Separation
18
18
Grounding Malfunction
17
17
Material Split, Cut or Torn
17
17
Unintended Movement
15
15
Insufficient Information
14
14
Temperature Problem
13
13
Electrical /Electronic Property Problem
11
11
Material Disintegration
9
9
Component Missing
8
8
Device Dislodged or Dislocated
6
6
Moisture Damage
6
6
Loose or Intermittent Connection
5
5
Radiation Output Problem
5
5
Overheating of Device
5
5
Output Problem
5
5
Failure to Clean Adequately
5
5
Unexpected Shutdown
5
5
Adverse Event Without Identified Device or Use Problem
5
5
Contamination /Decontamination Problem
5
5
Pitted
5
5
Improper or Incorrect Procedure or Method
5
5
Radiation Overexposure
5
5
Defective Component
4
4
Smoking
4
4
Installation-Related Problem
4
4
Misassembly During Maintenance/Repair
4
4
Naturally Worn
3
3
Unintended Collision
3
3
Particulates
3
3
Appropriate Term/Code Not Available
2
2
Structural Problem
2
2
Component Misassembled
2
2
Power Problem
2
2
Contamination
2
2
Tear, Rip or Hole in Device Packaging
2
2
Patient Device Interaction Problem
2
2
Off-Label Use
2
2
Loss of Power
2
2
Device Handling Problem
2
2
Defective Device
2
2
Separation Problem
2
2
Scratched Material
2
2
Complete Loss of Power
1
1
Device Damaged Prior to Use
1
1
Device Slipped
1
1
Ejection Problem
1
1
Misassembly by Users
1
1
Environmental Compatibility Problem
1
1
Protective Measures Problem
1
1
Separation Failure
1
1
Device Contamination with Chemical or Other Material
1
1
Accessory Incompatible
1
1
Material Deformation
1
1
Decoupling
1
1
Compatibility Problem
1
1
Battery Problem
1
1
Burst Container or Vessel
1
1
Material Twisted/Bent
1
1
Misassembled During Installation
1
1
Sparking
1
1
Fire
1
1
Circuit Failure
1
1
Activation Failure
1
1
Output above Specifications
1
1
Misassembled
1
1
Device Tipped Over
1
1
Inadequate Lubrication
1
1
Melted
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1501
1501
No Consequences Or Impact To Patient
519
519
No Known Impact Or Consequence To Patient
306
306
No Patient Involvement
125
125
Burn(s)
21
21
Insufficient Information
15
15
Injury
8
8
Full thickness (Third Degree) Burn
7
7
Skin Discoloration
5
5
Concussion
5
5
Bruise/Contusion
5
5
Laceration(s)
4
4
Headache
3
3
Superficial (First Degree) Burn
3
3
Foreign Body In Patient
3
3
Patient Problem/Medical Problem
2
2
Head Injury
2
2
Eye Injury
2
2
Bone Fracture(s)
1
1
Hematoma
1
1
Pain
1
1
Skin Tears
1
1
Burn, Thermal
1
1
Swelling
1
1
Burning Sensation
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Device Embedded In Tissue or Plaque
1
1
No Code Available
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
DKK Dai-Ichi Shomei Co., Ltd.
II
Oct-06-2023
2
GETINGE US SALES LLC
II
Mar-07-2019
3
Getinge Usa Sales Inc
II
Jan-19-2024
4
Getinge Usa Sales Inc
II
Jun-30-2022
5
Stryker Communications
II
Apr-09-2024
6
Stryker Communications
II
Mar-27-2020
7
Stryker Communications
II
Sep-12-2019
8
Stryker Communications
II
Aug-30-2019
9
Stryker Communications
II
May-21-2019
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